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Invotec Tracheal T-Tube

FDA UDI

Class II (US FDA UDI)

by Invotec International, Inc.

Identity

Trade Name
Invotec Tracheal T-Tube FDA UDI
Generic Name
Laryngectomy tube, non-sterile FDA UDI
Device Name
Invotec Tracheal T-Tube, Non-Sterile, 10.0cm Long FDA UDI
Model / Reference
1 FDA UDI
Description
Invotec Tracheal T-Tube, Non-Sterile, 10.0cm Long FDA UDI

Identifiers

Catalog Number
70-50101 FDA UDI
Primary DI / UDI-DI
00818501020089 FDA UDI
510(k) Number
K930114 FDA UDI
FDA Product Code
BTR FDA UDI
GMDN Term
Laryngectomy tube, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5730 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laryngectomy tube, non-sterile

Invotec Tracheal T-Tube by Invotec International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laryngectomy tube, non-sterile.

Cleared under the same submission

K930114 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Invotec International, Inc.

Sources (1)

  • FDA UDI 7b97a4c0-a56f-417d-a8a4-d22e503eef2a 35 fields · synced Jun 9, 2026